Associate Director, Regulatory Data Governance Lead

Role Summary

The Regulatory Data Governance Lead will ensure Regulatory information and data standards are aligned with Takeda’s strategic business requirements — including Master Data Management (MDM), Regulatory strategy, Industry standards, and evolving Health Authority (HA) expectations. In addition to supporting ongoing governance and data quality initiatives, this role will play a critical coordination role in Mergers & Acquisitions (M&A) activities: ensuring that data from acquired entities, products, and systems are properly assessed, migrated, and governed within Takeda’s Regulatory Information Management (RIM) ecosystem. The ideal candidate is a strong collaborator with an analytical mindset, experienced in metadata and data catalog management, and skilled at working across a highly federated organization. He/she will help integrate diverse data assets into Takeda’s systems, monitor the quality of Regulatory master and transactional data, and champion best practices in data stewardship, governance, and compliance.

Responsibilities

• 1. M&A Integration and Regulatory Data Transfer: Coordinate the assessment, transfer, and integration of Regulatory data during M&A activities, ensuring compliance with Takeda‚Äôs data governance standards.
• Support due diligence by reviewing acquired data sources, data models, and ownership structures to identify alignment needs and integration risks.
• Define and maintain data mapping and migration specifications for RIM and eDMS systems.
• Oversee the execution of data remediation, migration validation, and quality control activities.
• Liaise with DD&T, GRO, and cross-functional M&A integration teams to ensure consistent data ingestion and quality assurance across systems.
• Track data-related risks, issues, and lessons learned throughout acquisition integration projects.

Responsibilities

• 2. Regulatory Data Governance and Quality Management: Oversee the establishment and continuous improvement of Regulatory data governance policies and operating procedures.
• Identify and assign data standard roles (Data Quality, Stewards, Owners) across the Regulatory data domain.
• Maintain and evolve the Regulatory Data Catalog, ensuring proper data classification, lineage documentation, and quality rules.
• Define and monitor metrics to measure data and metadata quality, usability, and compliance with internal and external standards.
• Lead or support activities related to metadata management, including sensitive data tagging, business rule documentation, and data discoverability.

Responsibilities

• 3. Change and Stakeholder Management: Drive adoption of metadata and data governance practices through effective training and communication across stakeholder groups.
• Participate in data governance and M&A forums to align on priorities, report progress, and share best practices.
• Support Regulatory Intelligence and Change Management assessments to evaluate the impact of new regulations or process changes on data governance.
• Contribute to the definition of RIM data roadmap, architecture diagrams, and interface specifications.

Qualifications

• Bachelor‚Äôs degree in Life Sciences, Information Management, or related field; advanced degree preferred.
• 8+ years of experience in Regulatory Information Management, Regulatory Operations, or a related discipline within the pharmaceutical industry.
• Demonstrated experience in data integration, migration, or governance support within M&A or large-scale system transformation initiatives.
• Strong knowledge of Regulatory data models, RIM systems (Veeva Vault preferred), and Regulatory processes (Labeling, CMC, Registrations).
• Excellent analytical and problem-solving skills with attention to detail and compliance.
• Proven ability to coordinate across multiple stakeholder groups, balancing business and technical priorities.
• Experience working in GxP environments and hybrid cloud solutions preferred.